GMK REVISION EXTENSION

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Revision Extension.

Pre-market Notification Details

Device IDK123721
510k NumberK123721
Device Name:GMK REVISION EXTENSION
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
ContactAdam Gross
CorrespondentAdam Gross
MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-04
Decision Date2013-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030819438 K123721 000
07630030819339 K123721 000
07630030819346 K123721 000
07630030819353 K123721 000
07630030819360 K123721 000
07630030819377 K123721 000
07630030819384 K123721 000
07630030819391 K123721 000
07630030819407 K123721 000
07630030819414 K123721 000
07630030819421 K123721 000
07630030819322 K123721 000

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